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The Leaflex™ Standalone Study Protocol | Clinical Trials | Clareo Health

TERMINATEDNA

The Leaflex™ Standalone Study Protocol

NCT04649099•Pi-cardia

Summary

A prospective, multicenter, single-arm study aimed to assess safety and performance of the Leaflex™ Performer in the treatment of patients with symptomatic, severe aortic stenosis. Subjects will be seen at pre- and post procedure, discharge, 30 days and at 3, 6, 9 and 12 months post procedure.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patient with symptomatic, severe aortic stenosis who are not recommended by the heart team for immediate treatment with surgical or transcatheter aortic valve replacement.
•Patient is willing to comply with scheduled visits and tests and is able and willing to provide informed consent.

Exclusion Criteria

•Moderate or greater aortic regurgitation.
•Anatomic contraindications.
•Coronary, carotid, or vertebral artery disease that, in the opinion of the heart team, should be treated; or treatment of coronary artery disease ≤ 1 month prior to index procedure.
•Aortic balloon valvuloplasty ≤ 3 months prior to index procedure.
•Stroke ≤ 12 months prior to index procedure.
•History of a myocardial infarction ≤ 6 weeks prior to index procedure.
•Patients with clinically significant abnormality in cell blood count, history of bleeding diathesis or coagulopathy.
•Hemodynamic instability.
•Hypertrophic cardiomyopathy with obstruction.
•Left ventricle ejection fraction \<30%.
+2 more criteria

Locations (1)

Gottsegen Gyorgy Hungarian Institute of Cardiology

Budapest, Hungary

Key Dates

Start Date

September 2, 2020

Primary Completion Date

November 20, 2023

Completion Date

August 14, 2024

Last Updated

February 28, 2025

Enrollment

ACTUAL participants

Conditions

Aortic Valve Stenosis

Interventions

Leaflex™ Performer

DEVICE

Post-Dilatation Effect on TAVI Prostheses Expansion

NCT07477002

Aortic Valve Stenosis

View study

RECRUITINGPHASE4

ENAVOgliflozin Outcome Trial in Patients With Severe Aortic Stenosis After Transcatheter Aortic Valve Replacement

NCT05672836

Aortic Valve StenosisHeart Failure

View study

RECRUITING

Effect of Fetal Aortic Valvuloplasty on Outcomes

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 28, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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The Leaflex™ Standalone Study Protocol

Inclusion Criteria

Exclusion Criteria

Post-Dilatation Effect on TAVI Prostheses Expansion

ENAVOgliflozin Outcome Trial in Patients With Severe Aortic Stenosis After Transcatheter Aortic Valve Replacement

Effect of Fetal Aortic Valvuloplasty on Outcomes

Translational-Omics in Aortic Stenosis (TOmAS) Biobank

Structured Shared Decision Making for Patients Undergoing SAVR or TAVR

Myval Global Study of Myval™ THV Series Implanted in Patients With Native Severe Aortic Valve Stenosis.